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510(k) Data Aggregation

    K Number
    K012196
    Device Name
    ULTRACELL ABSORBENT STICK
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2001-08-24

    (42 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.
    Device Description
    Not Found
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    K Number
    K972633
    Device Name
    ULTRACELL SUCTION SPONGE
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-12-17

    (156 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neuro sponge drains are used during surgery to protect brain tissue from trauma, absorb fluids and to act as a filter to aspirate.
    Device Description
    Not Found
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    K Number
    K972634
    Device Name
    ULTRACELL SUCTION SPONGE
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-12-17

    (156 days)

    Product Code
    GDY, HBA, HOZ
    Regulation Number
    878.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.
    Device Description
    Not Found
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    K Number
    K973083
    Device Name
    ULTRACELL NEURO SPONGES
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-12-09

    (113 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neuro sponges are used during surgery to protect the brain tissue from dryness, trauma, absorb fluids and act as a filter to aspirate.
    Device Description
    Not Found
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    K Number
    K973558
    Device Name
    VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-11-24

    (66 days)

    Product Code
    FEB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.
    Device Description
    The use of an anti-fog solution aid to eliminate troublesome cloudiness which prevents clear vision and poor picture images. After application of the solution the device is ready for use. All ingredients are sterile. The solution will not harm the lens and can be used as often as necessary.
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    K Number
    K973085
    Device Name
    ULTRACELL PACKING WITH SLEEVE
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-11-18

    (92 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
    Device Description
    Not Found
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    K Number
    K972635
    Device Name
    ULTRACELL SUCTION SPONGE
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-10-01

    (79 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sponge drains are used during surgery to protect delicate tissue from trauma, absorb fluids and to act as a filter to aspirate
    Device Description
    Not Found
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    K Number
    K970328
    Device Name
    ULTRACELL NEURO SPONGES
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-04-21

    (84 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRACELL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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